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Health Highlights, April 22, 2021

COVID-19 Vaccines Safe for Pregnant Women: Study A new study adds to growing evidence that the Moderna and Pfizer COVID-19 vaccines are safe for pregnant...

They're on the Frontlines of the U.S. Vaccine Rollout

THURSDAY, April 22, 2021 (HeathDay News) -- April 16 was the first day that any Californian aged 16 or older became eligible to get the COVID-19 vaccine. And...

Biden Gives Businesses Incentives to Help Workers Get COVID Shots

THURSDAY, April 22, 2021 -- As demand for COVID-19 vaccination in the United States shows signs of declining, President Joe Biden on Wednesday offered...

Chocolate, Butter, Sodas: Avoid These Foods for a Healthier Middle Age

THURSDAY, April 22, 2021 -- It's no secret that too much sugar and saturated fat aren't good for you, but what food combos put you at greater risk for heart...

Two Is Not Better Than One When It Comes to Blood Thinners

THURSDAY, April 22, 2021 -- It may not be a good idea to take a daily low-dose aspirin if you're also taking a widely used class of blood thinners called...

FDA: Multiple Violations Found at Baltimore Plant Making COVID-19 Vaccines

WEDNESDAY, April 21, 2021 -- Improper disinfection and not following contamination prevention protocols are among the nine violations found by U.S. Food and...

Migraine Linked to Hypertension Among Menopausal Women

WEDNESDAY, April 21, 2021 -- For menopausal women, a history of migraine is associated with hypertension, according to a study published online April 21 in...

Supply May Soon Outstrip Demand in U.S. COVID-19 Vaccine Rollout

WEDNESDAY, April 21, 2021 -- Since the first COVID-19 vaccine was approved in December, millions of Americans have eagerly sought to find and receive one. But...

USPSTF: Evidence Lacking for A-Fib Screening in Asymptomatic Seniors

WEDNESDAY, April 21, 2021 -- The U.S. Preventive Services Task Force (USPSTF) concludes that the current evidence is insufficient to weigh the balance of...

Globally, No Increase Seen in Suicides in Early COVID-19 Pandemic

WEDNESDAY, April 21, 2021 -- In high-income and upper-middle-income countries, suicide numbers remained unchanged or declined in the early months of the...

U.S. FDA Approves ALK's Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis

ROUND ROCK, Texas, April 19, 2021 /PRNewswire/ -- ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on...

FDA Approves Opdivo (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma Regardless of PD-L1 Expression Status

PRINCETON, N.J.--(BUSINESS WIRE)-- April 16, 2021 Opdivo is the first and only immunotherapy in combination with chemotherapy to deliver superior overall...

FDA Approves Nextstellis (drospirenone and estetrol) Oral Contraceptive for Birth Control

GREENVILLE, N.C., April 16, 2021 /PRNewswire/ -- Mayne Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved Nextstellis (3 mg...

U.S. FDA Grants Accelerated Approval to Trodelvy for the Treatment of Metastatic Urothelial Cancer

FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 13, 2021-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has...

FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

South San Francisco, CA -- April 12, 2021 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug...

Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

COPENHAGEN, Denmark and BOTHELL, Wash.; April 09, 2021 – Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and...

Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis

NEW YORK--(BUSINESS WIRE) April 07, 2021 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has extended the priority...

CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia

SEATTLE, March 31, 2021 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has completed a rolling New Drug Application ("NDA")...

Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis

CAMBRIDGE, Mass., March 30, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives...

U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine

NORTH CHICAGO, Ill., March 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New...

FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

April 16, 2021 -- Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal...

Lilly Requests Revocation of Emergency Use Authorization for Bamlanivimab Alone to Complete Transition to Bamlanivimab and Etesevimab Together for Treatment of COVID-19 in the U.S.

INDIANAPOLIS, April 16, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has requested the U.S. Food and Drug Administration (FDA) revoke the Emergency...

Merck to Discontinue Development of MK-7110 for COVID-19

KENILWORTH, N.J.--(BUSINESS WIRE) April 15, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the discontinuation...

Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19

KENILWORTH, N.J., & MIAMI--(BUSINESS WIRE) April 15, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback...

Moleculin Awarded New Rare Pediatric Disease Designation from U.S. FDA for WP1066 for the Treatment of Ependymoma

HOUSTON, April 14, 2021 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a...

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